Sovalvir

Introduction
Sovalvir is an antiviral medication. It is used along with other medications for the treatment of chronic hepatitis C virus (HCV) infection. It works by lowering a load of hepatitis C virus in the body and removing the virus from the blood over a period of time. Sovalvir should be taken in the dose and duration as advised by your doctor. Do not skip any doses and finish the full course of treatment even if you feel better. It should be taken with food, preferably at a fixed time. If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. It has fewer side effects as compared to other similar medicines, like fatigue, headache, nausea, insomnia (difficulty sleeping) and anemia (low red blood cell count). Inform your doctor if these side effects persist for a longer duration. Please consult your doctor if you are pregnant, planning to conceive or breastfeeding.

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Uses of Sovalvir
Chronic hepatitis C virus (HCV) infection
Side effects of Sovalvir
Common
Fatigue
Nausea
Headache
Insomnia (difficulty in sleeping)
Anemia (low number of red blood cells)
How to use Sovalvir
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sovalvir is to be taken with food.
How Sovalvir works
Sovalvir is an antiviral medication. It works by lowering a load of hepatitis C virus in the body and removing the virus from the blood over a period of time.
What if you forget to take Sovalvir?
If you miss a dose of Sovalvir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
Sovalvir is used along with other medications for the treatment of chronic hepatitis C virus (HCV) infection.
Do not skip any doses and finish the full course of treatment even if you feel better.
It has fewer side effects compared to other similar medications.
Take it with food, preferably at the same time everyday.
You will usually need to take this medicine every day for either 12 or 24 weeks.
It may cause fatigue, dizziness, and blurred vision. Don’t drive or do anything requiring concentration until you know how it affects you.
Your doctor may monitor your liver function and the amount of hepatitis C virus in your body regularly.
Do not stop taking Sovalvir without your doctor’s advice.
Brief Description
Indication
Chronic Hepatitis C, Patients with hepatocellular carcinoma awaiting liver transplantation
Administration
Should be taken with food.
Adult Dose
Oral Chronic Hepatitis C One 400 mg tablet taken once daily with or without food – Should be used in combination with Ribavirin or in combination with Pegylated Interferon and Ribavirin for the treatment of CHC. Recommended combination therapy: (HCV Mono-infected and HCV/HIV-1 Co-infected ) Genotype 1 or 4 : Sofosbuvir + Peginterferon alfa + Ribavirin for 12 weeks Genotype 2: Sofosbuvir + Ribavirin for 12 weeks Genotype 3: Sofosbuvir + Ribavirin for 24 weeks – Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are Interferon ineligible – Should be used in combination with Ribavirin for treatment of CHC in patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation whichever occurs first – A dose recommendation cannot be made for patients with severe renal impairment or end stage renal disease

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Child Dose
Safety and efficacy not established

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Contraindication
When Sofosbivur is used in combination with Ribavirin or Peginterferon alfa/Ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Sofosbuvir combination treatment with Ribavirin or Peginterferon alfa/Ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant, because of the risks for birth defects and fetal death associated with Ribavirin.
Mode of Action
Nucleotide prodrug that undergoes metabolism to the active uridine analog triphosphate, an inhibitor of HCV NS5B RNA-dependent polymerase; its inhibition in turn suppresses viral replication .
Precaution
Pregnancy: Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least 2 effective methods of contraception and have monthly pregnancy tests. Lactation: Unknown if distributed in human breast milk; take into account the importance of therapy to the mother when administered combination with ribavirin and/or peg-interferon alfa; because of the potential for adverse reaction, breastfeeding is not recommended

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Side Effect
>10% Sofosbuvir plus ribavarin (12 weeks) Fatigue (38%),Headache (24%),Nausea (22%),Insomnia (15%),Pruritus (11%),Sofosbuvir plus ribavarin (24 weeks),Fatigue (30%),Headache (30%),Nausea (13%),Insomnia (16%),Pruritus (27%),Asthenia (21%),Diarrhea (12%) Sofosbuvir plus ribavarin plus peg-interferon (12 weeks) Fatigue (59%),Headache (36%),Nausea (34%),Insomnia (25%),Pruritus (17%),Anemia (21%),Rash (18%),Decreased appetite (18%),Chills (17%),Influenza-like illness (16%),Pyrexia (18%),Diarrhea (12%),Neutropenia (17%),Myalgia (14%),Irritability (13%) Sofosbuvir plus ribavarin plus peg-interferon (24 weeks) Fatigue (55%),Headache (44%),Nausea (29%),Insomnia (29%),Pruritus (17%),Anemia (12%),Rash (18%),Decreased appetite (18%),Chills (18%),Influenza-like illness (18%),Pyrexia (14%),Diarrhea (17%),Neutropenia (12%),Myalgia (16%),Irritability (16%) 1-10% Sofosbuvir plus ribavarin (12 weeks) Anemia (10%),Asthenia (6%),Rash (8%),Decreased appetite (6%),Chills (2%),Influenza-like sickness (3%),Pyrexia (4%),Diarrhea (9%),Myalgia (6%),Irritability (10%) Sofosbuvir plus ribavarin (24 weeks) Anemia (6%),Rash (9%),Decreased appetite (6%),Chills (2%),Influenza-like sickness (6%),Pyrexia (4%),Myalgia (9%),Irritability (10%) <1% Neutropenia,Pancytopenia,Severe depression (particularly in patients with pre-existing psychiatric illness) _ Pregnancy Category Note Pregnancy Category: B; Category X when used in combination with ribavirin or peginterferon alfa/ribavirin Interaction Reduced therapeutic effect w/ drugs that are potent P-gp inducers in the intestine (eg rifampicin, St. John's wort, carbamazepine & phenytoin), modafinil, phenobarb/oxcarbazepine, rifabutin/rifapentine. P-gp &/or BCRP inhibitors. May result in serious symptomatic bradycardia when co-administered w/ amiodarone in combination w/ another direct acting antiviral. _